Title : A novel approach to the treatment of heart failure by the application of a pulse-free constant direct electrical microcurrent
It has been shown in a pilot clinical trial with 10 patients with non-ischemic dilated cardiomyopathy and markedly impaired left ventricular ejection fraction that chronic application of a subthreshold constant direct current in the microampere range leads to a rapid and sustained improvement in cardiac function.
To achieve a current flow together with an electric field encompassing as large an area of the left ventricular myocardium as possible, it is necessary to place a patch electrode (electrically conducting area 30 cm²) epicardially over the free wall of the left ventricle. As a counter electrode, a coil electrode is placed in the right ventricle, which is advanced transvenously like the electrode of an internal defibrillator. The DC generator is positioned in a subclavian pocket, similar to the position of a pacemaker. Both electrodes are connected to the current generator via cables.
In a pilot study, 10 patients with non-ischemic dilated cardiomyopathy, a left ventricular ejection fraction (EF) of < 35 percent, and NYHA class III were treated with constant microcurrent over a 6-month period. After 6 months, EF showed a mean improvement of 9.8 percent (P < 0.001), six-minute walk distance (6-MWT) had nearly doubled on average (increase of 95 percent; P < 0.001), and NYHA class had improved by two classes in 80 percent of patients, by 1.5 in 10 percent of patients, and by only one class in 10 percent.
The application of microcurrent represents a completely new concept in the treatment of heart failure. Initial clinical data are extremely promising. A randomized pivotal trial with 100 patients is underway and will be completed by the end of the year. If successful, patients will certainly benefit from the use of microcurrent therapy who would otherwise have required heart transplantation or support with a mechanical ventricular assist device.